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Набор скоро начнётся NCT07725848

Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections

— Наблюдательное Complicated Urinary Tract Infections Antibiotic Resistance

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Complicated Urinary Tract Infections, Antibiotic Resistance. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
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Официальное название

Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections: an Observational Prospective Study

Обзор

This study is designed to better understand how well a new antibiotic combination, cefepime/enmetazobactam (FEP/META), works in patients with complicated urinary tract infections that have spread to the bloodstream (bacteremia). These infections are caused by bacteria that are resistant to several commonly used antibiotics, including bacteria that produce extended-spectrum beta-lactamases (ESBLs) or OXA-48 carbapenemases. The main goal of the study is to compare cefepime/enmetazobactam with the best currently available antibiotic treatments to see how quickly blood cultures become negative after treatment begins, which is an important sign that the infection is improving.

Подробное описание

The study aims to evaluate the time to blood culture negativization in patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers).

This is an investigator-initiated, observational, pharmacological, prospective multicenter cohort study that will enroll one hundred patients with urinary tract infection and bacteremia treated with cefepime/enmetazobactam, and an equal number treated with the best currently available antibiotic therapy.

Among the secondary objectives, the study aims to investigate clinical cure (defined as complete resolution of the signs and symptoms present at the time of screening) between the two groups, mortality at day 30 and day 90, the safety of cefepime/enmetazobactam, differences between the two groups in the trends of biological biomarkers, and differences in relapse rates between the two groups.

Первичные конечные точки

  • To evaluate the timing of microbiological eradication [Срок оценки: Within two weeks from the antibiotic therapy initiation]
Вторичные конечные точки (1)
  • To investigate clinical cure [Срок оценки: At day 3-7 after positive blood culture between two groups]

Критерии участия

Критерии включения

  • Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
  • Adult population (age ≥ 18 years)
  • Signed informed consent form

Критерии исключения

  • Polymicrobial/mixed infections (Gram-positive bacteria or fungi together with Gram-negative microorganisms), except in cases involving multiple Gram-negative bacteria susceptible to the study drugs
  • Patients with negative blood cultures
  • Isolation of Gram-negative microorganisms not susceptible to the study drugs (e.g., KPC-producing organisms)
  • Patients in palliative care or with a high likelihood of death within 72 hours from the index positive blood culture
  • Patients treated with inappropriate therapy for more than 48 hours
  • Patients discharged early without follow-up blood cultures
  • History of significant hypersensitivity or allergic reactions to cefepime, to any of the excipients in the respective formulations, or to beta-lactamase inhibitors (e.g., tazobactam)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Италия · 3 центра
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi — Catania
  • ASST Fatebenefratelli Sacco — Milan

Идентификаторы

NCT: NCT07725848 · CP-CUTI · 3438

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗